Optimization Mode of Innovative Chinese Medicine Formulations Based on Traditional Chinese Medicine Hospital Preparations

This study was aimed at investigating the optimization model of innovative Chinese medicine formulations based on traditional Chinese medicine (TCM) hospital preparations. A literature review was conducted to analyze the importance and characteristics of TCM hospital preparations. Then, the optimization process and methods of hospital preparations were summarized and explored. The results showed that hospital preparation is an important and fundamental resource of new drug development, with characteristics of abundant clinical experience, multiple formulations, multiple dosage forms, well-established efficacy and reliable safety. Hospital preparations may provide a rich material foundation for the screening of new drug development, which can shorten the development cycle and reduce research cost. However, there is still a gap between hospital preparations and innovative drugs. Based on our optimization work experiences, the optimization of hospital preparations should comply with the general principles and process of optimizing innovative Chinese medicine formulations, which can be divided into three parts, i.e., optimization of component formulation, optimization of clinical trial protocols and assessment before and after clinical trials. The optimization process should be well focused, so as to facilitate comprehensive optimization. Before optimization, the investigational prescription should undergo qualitative and quantitative evaluation for the first time. Based on the sponsor's final revision, the second qualitative and quantitative evaluation should be performed before the initiation of clinical trials. After clinical trials, the prescription should undergo qualitative and quantitative evaluation for the third time according to the findings of clinical trials. It was concluded that it is possible to provide an optimization model of innovative Chinese medicine formulations based on TCM hospital preparations.